MEPROBAMATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Meprobamate (UNII: 9I7LNY769Q) (Meprobamate - UNII:9I7LNY769Q)

Available from:

Taro Pharmaceutical Industries Ltd.

INN (International Name):

Meprobamate

Composition:

Meprobamate 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Meprobamate tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually do not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. Acute intermittent porphyria as well as allergic or idiosyncratic reactions to meprobamate or related compounds such as carisoprodol, mebutamate, tybamate, or carbromal.

Product summary:

Meprobamate Tablets USP, 200 mg are white, round tablets, scored on one side. Engraved "T" above the score and "M2" below the score line. Plain on the other side. Meprobamate Tablets USP, 400 mg are white, round tablets, scored on one side. Engraved "T" above the score and "M4" below the score line. Plain on the other side. Dispense in well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEPROBAMATE- MEPROBAMATE TABLET
TARO PHARMACEUTICAL INDUSTRIES LTD.
----------
MEPROBAMATE
TABLETS USP
CIV
RX ONLY
DESCRIPTION
Meprobamate is a white powder with a _characteristic odor_ and a
bitter taste. It is slightly soluble in
water, freely soluble in acetone and alcohol, and sparingly soluble in
ether. The structural formula of
meprobamate is:
C H N O M.W. 218.25
Meprobamate Tablets USP, 200 mg and 400 mg for oral administration
contain the following inactive
ingredients: colloidal silicon dioxide, magnesium stearate,
microcrystalline cellulose, pregelatinized
starch, sodium starch glycolate, and stearic acid.
CLINICAL PHARMACOLOGY
Meprobamate is a carbamate derivative which has been shown in animal
studies to have effects at
multiple sites in the central nervous system including the thalamus
and limbic system.
INDICATIONS AND USAGE
Meprobamate tablets are indicated for the management of anxiety
disorders or for the short-term relief
of the symptoms of anxiety. Anxiety or tension associated with the
stress of everyday life usually do not
require treatment with an anxiolytic.
The effectiveness of meprobamate tablets in long-term use, that is,
more than 4 months, has not been
assessed by systematic clinical studies. The physician should
periodically reassess the usefulness of
the drug for the individual patient.
CONTRAINDICATIONS
Acute intermittent porphyria as well as allergic or idiosyncratic
reactions to meprobamate or related
compounds such as carisoprodol, mebutamate, tybamate, or carbromal.
9
18
2
4
WARNINGS
DRUG DEPENDENCE
Physical dependence, psychological dependence, and abuse have
occurred. When chronic intoxication
from prolonged use occurs, it usually involves ingestion of greater
than recommended doses and is
manifested by ataxia, slurred speech, and vertigo. Therefore, careful
supervision of dose and amounts
prescribed is advised, as well as avoidance of prolonged
administration, especially for alcoholics and
other patients with a known propensity for taking excessive quantities
of drugs.
Sudden